Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Open to people ages 18 years and up

• Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
• Receiving BVY for ≥ 24 weeks prior to screening.

• Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
• History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
• Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
• Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
• Any of the following laboratory values at screening:
  • Clusters of differentiation 4 (CD4) cell count < 200 cells/mm³ at screening
  • Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula
  • Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
  • Direct bilirubin > 1.5 × ULN
  • Platelets count < 50,000 cells/mm³
  • Hemoglobin < 8.0 g/dL
• Active or occult hepatitis B virus (HBV) infection.
• Active hepatitis C virus (HCV).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.